ANZCTR search results

Recent investigations into a range of native Australian species grown commercially for the food industry have emphasised the need for further research into the potential health benefits of these species, in particular, Davidsonia pruriens (Davidson Plum). An open label exploratory pilot study is proposed to investigate the anti-inflammatory and antioxidant effects of an extract of Davidson Plum in humans. Additionally, a range of physical and cognitive screening tests will be trialled that incorporate known markers of health status, including lung function, grip strength, mobility impairment, mood and quality of life. It is hypothesized that the oral administration of the study medication over 2 weeks will result in a statistically significant change in markers of antioxidant and anti-inflammatory status. Both smokers and non-smokers will be enrolled. The analysis will look at the total population and then at smokers and non-smokers separately.

We hypothesize that ICU patients have changes in the structure of their small intestinal cells that predisposes them to malabsorption of nutrients. To investigate this, we are comparing biopsies from 15 ICU patients and comparing them to biopsies from 15 healthy patients. We will analyse the samples with an electron microscope.

Postnatal depression and anxiety in women are associated with disability and diminished caregiving capacity and are of national concern. The 2009 National Perinatal Depression Initiative addresses identification of and treatment for currently symptomatic women. However, a comprehensive health service response also requires strategies to promote mental health and prevent mental disorders. To date, interventions to prevent postnatal mental health problems have had limited success, perhaps because they focused only on women and did not include fathers or the baby; addressed needs for support by providing increased professional care rather than attempting to enhance a woman’s intimate relationships, and did not take history of mental disorders into account. The common agenda of the Victorian Department of Education and Early Childhood Development; the Mental Health Division of the Victorian Department of Health, the Parenting Research Centre and the Jean Hailes Research Unit, Monash University is to optimize maternal mental health and wellbeing through evidence-based universal approaches. This inclusive Partnership is essential to the implementation and testing of a novel intervention to meet these needs. What Were We Thinking (WWWT) is a well-theorized, salient, structured, gender-informed, couples-based early postpartum psycho-educational intervention provided in maternal and child health services. It addresses the intimate partner relationship, infant behaviour management, and the mediating effects of occupational fatigue. We have promising early evidence from a controlled before and after study that WWWT prevents postpartum mental health problems in women. This cluster randomized controlled trial will establish whether WWWT is effective in reducing the 30 day prevalence of depression, anxiety and adjustment disorders in primiparous women and improving infant behaviour, mother-infant relationship and partner relationship at six months postpartum.

Clinicians consider arterial oxygen saturation (SpO2) of at least 88-90% as an acceptable target for most patients undergoing mechanical ventilation (MV). Although several experimental and clinical studies report that high levels of oxygen (O2) may be injurious, and recent RCTs show that O2 therapy titrated to lower SpO2 targets (88-94%) improves clinical outcomes in some patient groups, major observational studies show that ICU patients often receive much higher levels of oxygenation in the first 24 hours of ICU admission. Indeed, in a recently completed observational study in ICU patients on MV, we observed that high oxygenation levels were usually achieved with the use of liberal amounts of O2 in routine practice. At a teaching hospital, the 95% confidence interval for the mean time-weighted average SpO2 for the first 7 days of ventilation was 96.8-97.4% and the mean FiO2 of 0.40 or more was used to achieve mean SpO2 of >95% on 40% of the ventilated days. There are no data in literature, for adult ICU patients receiving MV, to demonstrate whether or not higher oxygenation targets (SpO2 >95%) lead to different outcomes than the alternative lower targets (SpO2 88-94%). We aim to systematically evaluate whether liberal O2 therapy is beneficial or harmful compared to a more conservative O2 therapy in critically ill patients. To help us determine the optimal size and design of a suitable trial, a pilot study will be first performed to assess feasibility of the two oxygenation strategies. Our hypothesis for this pilot study is that in critically ill patients on invasive MV, an effective separation of SpO2 levels can be achieved between the two (conservative vs. liberal oxygen targets) groups, without any significant problems or safety concerns in implementing the study protocol in different critical care settings. 100 eligible patients, will be randomly allocated to either a liberal oxygenation strategy with target SpO2 of at least 96% or a conservative oxygenation strategy with target SpO2 of 88-92%. The treating team will set PEEP as per usual practice. When FiO2 requirements are >0.80, SpO2 targets will be determined by the treating clinicians. The pragmatic nature of the trial allows flexibility in management decisions and allows the treating clinicians to alter oxygenation targets if necessary according to patient’s current clinical state. Other co-interventions such as sedation, nutrition and weaning from ventilation will follow standard practices. This pilot study will provide crucial preliminary information on the likely effects of two different target levels of oxygenation in ICU patients on invasive MV. If feasibility and safety are demonstrated, we will follow this study with a definitive RCT, the results of which will have the potential to substantially influence clinical practice in relation to O2 therapy in critically ill patients.

Anaemia associated with Chronic Kidney Disease (CKD) is due to the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin (EPO), as well as, the shortened lifespan of red blood cells (RBCs), iron and other nutritional deficiencies, infection, and inflammation. The prevalence of anaemia increases with progressive deterioration of renal function, and affects more than 90% of people with end stage renal disease. Anaemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function and exercise capacity, and increased left ventricular hypertrophy and heart failure. Treatment of anaemia reduces morbidity and may improve quality of life (QoL). Erythropoietin Stimulating Agents have been established as an effective treatment for anaemia associated with CKD and have improved the management of anaemia over alternatives such as blood transfusion. The first approved recombinant human erythropoietin, epoetin alfa, is administered 2-3 times/week for maximum efficacy. Darbepoetin alfa, has a longer half life allowing for less frequent dosing. Methoxy-polyethylene glycol-epoetin beta is a pegylated product that can be administered once monthly. PSA-EPO is a polysialylated form of erythropoietin (EPO), which is being developed for the treatment of anaemia of CKD. It is thought that polysialylation might produce an improved form of EPO, requiring a lower frequency of injection, have a slower onset of action than EPO, and potentially avert some of the side effects noted for EPO (e.g., thrombotic cardiovascular events). This is a phase 2, open-label, multi-centre and sequential dose finding trial with up to 6 treatment cohorts of 12 pre-dialysis participants per cohort will enrol between 24 and 90 participants >18 years of age with anaemia secondary to CKD, and not had treatment with an ESA in the prior 10 weeks. Two dose level cohorts are initially planned to be sequentially enrolled. Depending on the observed safety profile and pharmacological response, up to four additional open-label cohorts of 12 participants per cohort may be subsequently added to study additional and/or repeat dose levels of PSA-EPO, as determined by a safety review committee. Each participant will receive an open-label dose of PSA-EPO every 2 weeks in the correction phase, and every 4 weeks once the target haemoglobin level has been achieved, for a total of up to 8 doses. The first cohort will receive a starting dose of 1 microgram/kg body weight administered subcutaneously every two weeks. Each participant who completes the study is expected to participate for at least 17 weeks following the screening and attend weekly visits (unless advised differently by the local principal investigator) during that time.

We are implementing the WSC for residential aged care adults with dementia in the Brisbane and Toowoomba area. This project aims to rekindle positive memories of swimming in people with dementia and get them involved in a safe, regular physical activity. Swimming is an activity that has the capacity to address physical health needs, because it involves exercise; psychological health needs, because it is fun and relaxing; and social health needs, because it involves interactions with other people. Further, we aim to investigate whether participation in an evidence-based aquatic exercise program leads to changes in adults’ quality of life for adults with dementia living in residential aged care facilities, in terms of behavioural and psychological symptoms, depression and physical health. In our pilot study, conducted in Toowoomba in 2011, we showed that the WSC has the potential to positively influence sleep, appetite, pain, falls resistance, behavioural and psychological symptoms of dementia, depression, physical strength and flexibility and social functioning. The results of the pilot study showed that the WSC intervention improved left hand grip and psychological well-being, decreased the number of behavioural and psychological symptoms of dementia expressed and decreased the extent to which these behaviours distressed staff. In our current research project, we are predicting that there will be greater improvements to the quality of life of adults participating in the WSC, compared to adults receiving usual care. (For information about the pilot study, please see the following publications: (1) Neville, C., et al. (2013). "Watermemories: a swimming club for adults with dementia." Journal of gerontological nursing 39(2): 21-25; (2) Henwood, T., et al. (2012). "The Watermemories Swim Club for people with dementia." Australasian Journal on Ageing. 31(S2): 13, 23-24, 41; (3) Neville, C., et al. (2012). "The Watermemories Swim Club for People with Dementia." Journal of Ageing and Physical Activity. 20(August): S8 - 10.) Finally, we aim to create a sustainable, cost-effective, evidence-based exercise program that can be easily accessed and implemented by RACFs, independent of a research environment. To achieve this objective, we intend to disseminate manuals describing the WSC program and outlining in detail how it can be implemented, so that it may be incorporated into RACFs in other areas of Australia

Many people with depression do not access treatment. Internet-based therapies are proven in efficacy and effectiveness. Bibliotherapy may provide an easier way to deliver self-guided treatment, but efficacy is rarely established. A trial comparing internet CBT, CBT via a self help book, and meditation via a self help book has not been performed to our knowledge. This research will allow the community to make a more informed choice about what form of readily available treatment to choose from for depression.

The low FODMAP diet is effective in managing symptoms in many patients with irritable bowel syndrome. To assess if liberalisation of the diet is possible while still maintaining good symptom control, it is hypothesised that longer-chain FODMAP sugars (inulin) is less fermentable and less osmotic in the large intestine and will therefore not contribute to symptoms as much as shorter-chain FODMAPs (fructo-oligosaccharides and lactulose). Glucose is not a FODMAP, but a sugar that is well absorbed and it is hypothesised that glucose will not contribute to symptoms. Diarrhoea-predominant patients with reported good symptom control on a low FODMAP diet will be recruited for easier measuring of symptom change, bowel motions and faecal water content specifically.

Diarrhoea amongst hospitalised patients receiving enteral formula (tube-feeding) is common. Previous research has suggested that one possible reason for this is the high content of poorly absorbed sugars called FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) in the formula. FODMAPs enter the large intestine where they get fermented by bacteria, produce gas and draw water in to the large intestine. In large enough doses, this may contribute to diarrhoea. We hypothesise that giving a formula we believe is high FODMAP compared to a formula we believe is low FODMAP will produce different amounts of large intestinal gas. This can be measure by collecting the breath after drinking these formulas and measuring the levels of gas in the breath. We will then compare this to a the FODMAP lactulose, which is a sugar that is known to produce gas in everyone. This will show us if there are FODMAPs in the formulas and a rough estimation of quantity.

The study tests the effectiveness of LASER acupuncture on osteo arthritis knee (OAK) pain. OAK is the most common form of arthritis. OAK sufferers and LASER and acupuncture practitioners would benefit from the study in a number of ways. For example, a positive outcome: 1. Would determine an effective LASER acupuncture treatment protocol and influence clinical practice. 2. May help reduce dependency on pharmacological treatments and alleviate associated drug side effects. 3. May reduce the cost and/or financial burden of OA treatment for individuals and the community as a whole. 4. Would help increase awareness about the choice of available treatments. A negative study outcome: 1. May prove the null hypothesis correct (i.e. LASER acupuncture is not effective for OAK). 2. Would encourage further investigations to test the validity of the study design or develop new experiments.